BEUDAMED
    FDA Enforcement Class I Terminated

    HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit

    Recall: Z-1112-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1112-2020
    Event ID
    84588
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    TELEFLEX MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    December 13, 2019
    Classification Date
    February 7, 2020
    Termination Date
    April 30, 2024
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit

    Reason

    There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.

    Code Info

    GTIN 14026704659361 Lot Numbers: 74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071

    Distribution

    nationwide

    Quantity

    30566 devices